IRVINE, Calif., June 12 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced today that three new independent studies demonstrating the clinical accuracy and utility of Masimo PVI as a noninvasive and continuous measure of patient fluid status and responsiveness were presented this week at the European Society of Anaesthesiology (ESA) Annual Congress in Milan, Italy.
Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality. Traditional invasive measurements such as central venous pressure are not reliable to predict whether a patient will benefit from fluid administration, and newer more reliable methods to predict fluid responsiveness are also invasive and costly. Multiple recent studies have shown that Masimo PVI provides a simple and cost-effective method for accurate, noninvasive, and continuous monitoring of fluid responsiveness. The three studies presented at the ESA reinforce the accuracy of PVI compared to invasive measures and highlight its value for before, during, and after anesthesia.
Does the Pleth Variability Index correlate with stroke volume variation? Researchers in the Department of Anesthesiology at the Hamamatsu University School of Medicine in Hamamatsu-City, Japan, compared the accuracy of Masimo PVI measurements with Stroke Volume Variation (SVV) obtained via an invasive catheter (Flo Trac(R)) in 13 patients. After analyzing data recorded at five points--in the supine position, lateral position, start and end of one-lung ventilation, and in the supine position again--researchers found a significant correlation between PVI and SVV (r = 0.75; p = 0.02). The study concluded that "Our results suggest that an accurate prediction of fluid responsiveness can be obtained non-invasively using the PVI."(1)
The Change of Upper Limbs PVI in Spinal Block (Comparison in High Spinal Block and Non-High Spinal Block)
Perfusion Index and Pleth Variability Index After Administration of General Anesthetic Agents
In this study, anesthesiologists at the Teikyo University School of Medicine in Tokyo, Japan, analyzed changes in PVI and Masimo perfusion index (PI) in 21 surgical patients before and after administration of general anesthetic agents. After administration of general anesthetic agents and 10ml/kg/hr of fluid during induction, PVI significantly decreased from 22.9=/+8.1 to 17.1=/+7.2 (p<0.05) and PI significantly increased from 2.1=/+1.7 to 3.8=/+2.3 (p<0.001), leading researchers to conclude that "an increase in peripheral perfusion and improvement of fluid status and preload" occurred "after administration of general anesthetic agents and intravenous fluid administration during anesthesia induction."(3)
Michael O'Reilly, MD, EVP of Medical Affairs at Masimo, stated; "These studies confirm what previous results have shown--that PVI's accuracy at predicting fluid responsiveness is better than traditional measurements and similar to the newer invasive monitoring techniques at fraction of the cost and complexity. Because PVI is noninvasive and is available from the same sensor used with Masimo Rainbow SET(R) Pulse CO-Oximeters, it has the strong potential to expand and improve fluid monitoring and management in patients who would otherwise not be monitored with the newer invasive techniques."
PVI is available as part of Masimo Rainbow SET Pulse CO-Oximetry(TM)--the first-and-only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures, including: noninvasive and continuous total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI, in addition to the 'gold standard' Measure-Through Motion and Low-Perfusion performance of Masimo SET(R) oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI).
1.Y. Kawashima, Y. Shiraishi, S. Sato. Does the Pleth Variability Index correlate with stroke volume variation?. Eur J Anaesthesiol 2009; 26 (Suppl 45): 3AP5-9
2. K. Takeyama, M. Yoshikawa. The change of upper limbs PVI in spinal block (The comparison in high spinal block and non-high spinal block). Eur J Anaesthesiol 2009; 26 (Suppl 45): 3AP5-1
3. J. Mizuno, Y. Morita, A. Kakinuma, S. Morita. Perfusion Index and Pleth Variability Index after administration of general anesthetic agents. Eur J Anaesthesiol 2009; 26 (Suppl 45): 4AP8-3
Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care--helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through-Motion-and-Low-Perfusion pulse oximetry, known as Masimo SET, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." Additional information about Masimo and its products may be found at www.masimo.com.
Forward Looking Statements
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results, risks related to our belief that Masimo SpHb and PVI will provide a sufficient level of sensitivity and specificity to facilitate continuous measurement capabilities and deliver clinical improvement over alternative hemoglobin and fluid assessment measurement capabilities to allow for further adoption of the technology, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the "Risk Factors" contained in our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Contact: Dana Banks Masimo Corporation 949-297-7348
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